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The purpose of this study is to investigate the safety and effectiveness of trigeminal nerve electrical stimulator on reducing the frequency of migraine onset. It is applied to migraine patients and analyzes the results by comparing them before and after 4weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | N=20 60Hz pulse electrical stimulation The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elexir (trigeminal nerve electrical stimulator) | Device | Elexir performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of days of moderate to severe headache | Check the number of days of moderate to severe headache at 4 weeks after start compared to baseline | baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of headache days | Check the number of headache days in 4 weeks after the start of stimulation compared to the baseline | baseline, 4 weeks |
| Change in the frequency of headache days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
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Check the frequency of headache days in 4 weeks after the start of stimulation compared to the baseline
| baseline, 4 weeks |
| Change in the frequency of taking the acute phase drug | Check the frequency of taking the acute phase drug in 4 weeks after the start of stimulation compared to the baseline | baseline, 4 weeks |
| Change in pain intensity when headache occurs | Check the change in pain intensity when headache occurs in 4 weeks after the start of stimulation compared to the baseline | baseline, 4 weeks |
| Change in the headache effect assessment (HIT-6) score | Check the change in the headache effect assessment (HIT-6) in 4 weeks after the start of stimulation compared to the baseline | baseline, 4 weeks |
| Change in the migraine-related quality of life (MSQ 2.1) score | Check the migraine-related quality of life (MSQ 2.1) change in 4 weeks after the start of stimulation compared to the baseline MSQ 2.1 measures the impact of migraine across three essential aspects. The MSQ total and scale score varies between 0 and 100 with higher scores indicating higher impact. | baseline, 4 weeks |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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